Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)

Phase 2-3 - Memantine for Disability in Amyotrophic Lateral Sclerosis

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00353665

Enrollment

Registered

2006-07-19

Start date

2005-07-31

Completion date

2009-01-31

Last updated

2009-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosis, motor neuron disease, memantine, clinical trial

Brief summary

The purpose of this trial is to study the effect of Memantine (uncompetitive, moderate affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the calcium influx into the neurons), a drug used to treat Alzheimer´s disease, on the progression of Amyotrophic Lateral Sclerosis (ALS). Memantine is added to riluzole (the single drug approved to treat ALS).

Detailed description

Phase 2/3 trial in ALS patients Double-blinded, parallel, randomized (2 blocs, bulbar/spinal onset) Memantine + riluzole x Placebo + Memantine Inclusion criteria: * \< 75 years at disease onset * \< 3 years of disease progression * ALS-FRS \> 24 * FVC \> 60 * Probable or definite disease (revised El Escorial criteria) * No other medical condition * Normal blood tests * Regular medication on riluzole \> 1 month * Nerve conduction studies ruling out conduction block * EMG with widespread loss of motor units (revised El Escorial criteria) * At least one hand with ADM strength \> 2 on MRC scale Duration - 2 years Evaluation - every 3 months Primary outcome - ALS-FRS Secondary -SF36, Hamilton depression scale, motor unit number estimation, neurophysiological index, strength (clinical evaluation); side-effects Intention to treat analysis 60 patients number estimated for 50% change in decline rate of ALS-FRS

Interventions

DRUGMemantine (Ebixa)

10 mg bid

DRUGriluzole

riluzole 50 mg bid

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Definite or probable disease - revise El Escorial criteria * Normal blood tests * Riluzole treatment during 1 month or more * EMG in accordance with El Escorial criteria

Exclusion criteria

* Other diseases (such as PNP) * Both ADM muscles \< 3 on MRC scale * Conduction block on nerve conduction tests * Disease duration \> 3 years * ALS-FRS \< 25 * Forced vital capacity - \<60%

Design outcomes

Primary

Measure	Time frame
ALS-FRS	12 months

Secondary

Measure	Time frame
QoL, depression scale, strength (clinical evaluation), forced vital capacity	12 months
neurophysiology (motor unit counting, neurophysiological index)	12 months

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026